DePuy Orthopaedics Faces Federal False Claims Act Lawsuit


2017-11-28

DePuy Orthopaedics and parent company Johnson & Johnson have already been told by a jury they’ll have to pay around $247 million to settle lawsuits related to their hip replacement devices.

The two companies also now face a revised version of a federal lawsuit alleging they violated the False Claims Act by misleading the government about the safety of their Pinnacle metal-on-metal hip devices.

Meanwhile, attorneys are investigating lawsuits concerning the DePuy Synthes Attune replacement devices.

Allegations Involve Misleading the Government

According to the False Claims Act lawsuit, filed in Massachusetts federal court by Antoni Nargol and David Langton, DePuy and Johnson & Johnson marketed their Pinnacle hip replacement systems as being far safer than they actually were.

This is the second time the companies have faced such a claim—the first time a lower court dismissed the allegations, but the lawsuit was revived in July 2017 based on the allegations of indirect false claims, Law360 reports.

The plaintiffs allege DePuy misled the government about both the safety of the hip implants and their failure rates, and that the government would not have paid claims linked to the devices if the marketing had been truthful.

The lawsuit is U.S. et al. vs. DePuy Orthopaedics Inc. et al., case number 1:12-cv-10896 in the U.S. District Court for the District of Massachusetts.

Johnson & Johnson Ordered to Pay $247 Million

Adding to DePuy’s woes, Johnson & Johnson was ordered by a Texas jury to pay $247 million to six plaintiffs who alleged the companies lied about issues with its Pinnacle hip implants, putting them at risk of receiving a defective device. In ordering the payment, the jury found that DePuy officials knew the hips were defective but did not warn doctors or patients about any perceived risks in having the devices implanted.

The jury awarded $79 million actual damages and $168 million in punitive damages to the six plaintiffs.

Each of the six plaintiffs alleged they received DePuy Pinnacle hip implants that failed early and had to be removed and replaced with new devices.

The Pinnacle has not been available on the market since 2013, but lawsuits filed regarding the device continue to grow as more patients experience device failure.

Included in the settlement were:

  • Uriel Brazel, 88 years old
  • Karen Kirschner, 67 years old
  • Ramon Alicea, 61 years old
  • Hazel Miura, 60 years old
  • Eugene Stevens, 53 years old
  • Michael Stevens, 52 years old.

The plaintiff’s alleged officials pushed the Pinnacle for market approval without undergoing proper testing and further misled doctors about the safety profile. Included in the injuries patients say they suffered were metal poisoning—caused when metallic debris from the devices comes loose and is absorbed by the surrounding tissue—and early device failure.

When hip implants fail, patients may have to undergo complicated revision surgery to remove and replace the device.

The lawsuit is In Re: DePuy Orthopaedics Inc. Pinnacle Hip Implants Products Liability Litigation, 11-md-2244, U.S. District Court for the Northern District of Texas (Dallas).

DePuy Faces International Claims Related to Pinnacle

In addition to claims in the U.S., DePuy and Johnson & Johnson also face claims in the U.K. regarding the Pinnacle hip implant. There, lawsuits allege that safety studies on the devices were flawed, which resulted in improper data regarding the effectiveness of the implants.

An expert testifying in the High Court said the metal-on-metal devices were not properly cleaned during studies, which could have affected the results of the testing, making it seem the implants suffered less wear and tear than they did.

Attorneys Investigating Claims Regarding DePuy Synthes Knee Replacement

In addition to concerns about the DePuy Pinnacle—and the DePuy ASR, which resulted in its own massive settlements—patients have issued concerns about the DePuy Attune Knee replacement system. Those concerns include allegations that early failure of the device can cause severe pain, muscle damage, and bone loss, and require revision surgery.

There has been no DePuy Attune recall announced, despite concerns about the early failure rate.

At least one lawsuit has been filed against DePuy regarding the company’s Attune Knee System. The lawsuit alleges the system was marketed as improving a patient’s range of motion and providing a stable knee replacement. On the contrary, the plaintiff claims, the Attune Knee System can cause knee destabilization and require revision surgery.

Some physicians say the issue appears to be that the cement used to hold the implant in place did not properly adhere to the bone, allowing the bone and the implant to come loose.

Symptoms of loosening of the knee implant:

  • Pain
  • Reduced mobility
  • Warmth at the implant site
  • Swelling
  • Reduced Mobility
  • Infection
  • Inflammation
  • Fracture
  • Tissue Damage

DePuy Synthes Attune Knee System Lawyer

Attorneys at Patterson Dahlberg Injury Lawyers are highly experienced in protecting the rights of patients who have suffered harm thanks to defective medical devices.

If you or a loved one has been harmed by the use of a DePuy Synthes Attune Knee System Lawyer, contact us today to discuss your legal options.

We’re available for a no-obligation case evaluation and can answer your questions and advise you of your rights.